Multiple Sclerosis, MSNCT06800144
Effect of Music Therapy on Pain in People With Multiple Sclerosis
A study testing Heart rate synchronized motor imagery music therapy and Heart rate synchronized music therapy in people with Multiple Sclerosis, MS, run by Istanbul Bilgi University at 1 site in Turkey (Türkiye).
Trial summary
Multiple sclerosis (MS) is a chronic, inflammatory, demyelinating and progressive neurological disease of the central nervous system, often seen between the ages of 20-30. Pain is a very common symptom in people with MS, with a prevalence of 63%. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, MS
- What is being tested?
- Heart rate synchronized motor imagery music therapy and Heart rate synchronized music therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2026to 12 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being between the ages of 18-65.
- Having a definite MS diagnosis according to the 2017 McDonald criteria.
- Having a pain level of at least 3 and above on the numerical pain scale for at least 3 months.
- Not having had an attack in the last 3 months.
- Having a tablet or computer with an active internet connection that is suitable for videoconferencing.
- Having a smartphone to which the heart rate monitor can be connected with the Bluetooth feature so that the heart rate synchronized music therapy training can be given.
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- Having sufficient smartphone/tablet or computer knowledge to participate in the study or having a relative who can help in this regard.
- No change in the medications used for pain in the last 2 months.
- Not receiving any additional treatment other than routine treatments.
- Being able to read and understand Turkish.
Who cannot join
- Having a serious musculoskeletal, cardiovascular, pulmonary, metabolic or other disease that would prevent participation in the study.
- Having a condition other than MS that can cause pain, such as cancer, diabetes, significant osteoarthritis or rheumatoid arthritis, based on laboratory or imaging findings
- Having a psychiatric disease (such as active psychotic disorders, severe depression, anxiety disorders) that would prevent participation in the study and having a serious cognitive disorder determined by a physician that would prevent testing
- Having a serious vision or hearing problem.
- Being pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Telerehabilitation-Based Heart Rate-Synchronized Motor Imagery Music Therapy on Pain, Autonomic Function and Psychosocial Parameters in People With Multiple Sclerosis
Multiple sclerosis (MS) is a chronic, inflammatory, demyelinating and progressive neurological disease of the central nervous system, often seen between the ages of 20-30. Pain is a very common symptom in people with MS, with a prevalence of 63%. Pain in MS is a symptom that negatively affects individuals' fatigue, anxiety and depression levels, quality of life and sleep quality. In addition, chronic pain affects individuals' autonomic and cognitive functions. Music therapy is defined as the systematic use of music in a therapeutic relationship that aims to improve, maintain and develop emotional, physical and mental health. Music therapy protocols synchronized with heart rate can be effective on chronic pain through the regulation of the autonomic nervous system and activation of the parasympathetic nervous system. Studies indicate that music therapy, regardless of the population applied, is effective in the management of symptoms such as pain, depression and anxiety. Motor imagery training is a method that regulates cerebral cortex activity by exposing the brain to visual information and imagination, reduces abnormal cortical activation, and thus restores the brain's ability to change. Research indicates that the most effective motor imagery training in reducing pain is motor imagery training presented in a protocol graded from simple to complex motor tasks.
The grading principle applied in motor imagery training in the form of imagining movements from simple to complex and music therapy training presented in a rhythm matched with heart rate rhythm are effective approaches on chronic pain. It is thought that the treatment protocol in which these two methods are combined and their therapeutic effects are combined in MS rehabilitation may be more effective on pain and related factors in MS. The aim of the study is to show the effects of telerehabilitation-based heart rate-synchronized music therapy protocols on pain, heart rate, fatigue, anxiety, depression, quality of life, sleep quality, and information processing speed compared to MS individuals who continue their routine treatments.
45 MS people with chronic pain will be included in the planned randomized controlled trial. The included participants will be randomized into 3 groups with 15 participants in each group. The evaluations will be performed three times before treatment, at 8th (post-treatment evaluation) and 12th weeks (follow-up evaluation). The participants' general pain intensity in the last 2 and 7 days, the presence of neuropathic pain, fatigue level, anxiety and depression levels, sleep quality, health-related quality of life and information processing speed will be evaluated. In addition, heart rate variability will be evaluated in order to evaluate the participants' autonomic functions. Telerehabilitation-based music therapy application will be given to the participants 2 days a week for 8 weeks using a videoconferencing platform under the guidance of a physiotherapist. The heart rates of the participants will be monitored throughout the session. The participants included in the first group will visualize the movements presented with the metronome sound in a rhythm matched to their heart rates, while the participants included in the second group will listen to relaxing/relaxing music without lyrics in a rhythm matched to their heart rates. When synchronization is achieved between the music rhythm and the heart rate in both groups, the music rhythm will be reduced. Participants included in the 3rd group will continue their routine treatment and will be evaluated only three times: at the beginning, after the 8th week and after the 12th week. The results obtained from this study will examine the effects of heart rate synchronized music therapy protocols on pain, autonomic function and psychosocial parameters in individuals with chronic pain and MS.
- Conditions
- Multiple Sclerosis, MS
- Being tested
- Heart rate synchronized motor imagery music therapy, Heart rate synchronized music therapy
- Keywords
- Music Therapy in Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart rate synchronized motor imagery music therapyBehavioural
Participants included in this group will listen a metronome sound in a rhythm synchronized with their heart rate.
Heart rate synchronized music therapyBehavioural
Participants included in this group will listen to soothing/relaxing music without lyrics in a rhythm synchronized with their heart rate.
| Study group | Role | What they receive |
|---|---|---|
| Heart rate synchronized motor imagery music therapy | Experimental | Participants included in this group will imagine the movements presented to them with a metronome sound in a rhythm synchronized with their heart rate. Receives: Behavioral: Heart rate synchronized motor imagery music therapy |
| Heart rate synchronized music therapy | Active comparator | Participants included in this group will listen to soothing/relaxing music without lyrics in a rhythm synchronized with their heart rate. Receives: Behavioral: Heart rate synchronized music therapy |
| Control group | No intervention | Participants included in this group will continue their routine treatment and will only be evaluated three times: at the beginning, after 8 weeks and after 12 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
The general pain intensity felt by people with MS participating in the study in the last 2 and 7 days will be assessed using the Visual Analogue Pain Scale. The scale ranges from 0 mm to 100 mm, with higher values indicating greater pain intensity.
Measured: Baseline, week 8 and week 12
Secondary outcomes (9)
PainDETECT
'PainDETECT' will be used to assess neuropathic pain in people with MS participating in the study.
Measured: Baseline, week 8 and week 12
Nordic Musculoskeletal Questionnaire
The 'Nordic Musculoskeletal Questionnaire' will be used to assess the pain of MS patients participating in the study according to their body regions.
Measured: Baseline, week 8 and week 12
Central Sensitization Questionnaire- Short Form
The Central Sensitization Questionnaire-Short Form is a participant-reported measurement tool designed to assess the presence of central sensitization and its associated symptoms.
Measured: Baseline, week 8 and week 12
Modified Fatigue Impact Scale
The 'Modified Fatigue Impact Scale', which is frequently used in clinical and experimental studies, will be used to determine the fatigue level of people with MS participating in the study. The scale ranges from 0 to 84, with higher values representing increased levels of fatigue.
Measured: Baseline, week 8 and week 12
Hospital Anxiety and Depression Scale
The 'Hospital Anxiety and Depression Scale' will be used to evaluate the anxiety and depression levels of people with MS participating in the study. The questionnaire has seven items each for depression and anxiety subscales. Scoring for each item ranges from zero to three, with three denoting highest anxiety or depression level. A total subscale score of >8 points out of a possible 21 denotes considerable symptoms of anxiety or depression.
Measured: Baseline, week 8 and week 12
Preference Based MS Index
The Preference-Based MS Index will be used to assess patient-reported health-related quality of life.
Measured: Baseline, week 8 and week 12
Pittsburgh Sleep Quality Index
The subjective sleep quality of individuals with MS participating in the study will be evaluated using the 'Pittsburg Sleep Quality Index (PSQI)'.
Measured: Baseline, week 8 and week 12
Heart Rate Variability
Heart rate variability is an important parameter of cardiac autonomic modulation and provides information about the autonomic nervous system functions of individuals.
Measured: Baseline, week 8 and week 12
Paced Auditory Serial Addition Test
Paced Auditory Serial Addition Test (PASAT) will be used to assessment the cognitive functions of the participants included in the study.
Measured: Baseline, week 8 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start1 Mar 2026
- Primary completion10 Jul 2026
- Study completion12 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis, MSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Bilgi University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Hilal Karakas, Istanbul Bilgi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06800144
- Sponsor's protocol ID
- MusicTherapy
- Status last verified
- Aug 2026
- First submitted
- 20 Jan 2025
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karakas H, Ertekin O, Yavas I, Gozubatik-Celik RG, Kazdagli H, Seebacher B, Kahraman T. Effect of Telerehabilitation-Based Music Therapy and Motor Imagery on Pain, Autonomic Function, and Psychosocial Outcomes in People With Multiple Sclerosis: A Randomized Controlled Trial Protocol. Physiother Res Int. 2026 Apr;31(2):e70186. doi: 10.1002/pri.70186.
PubMed 41791797
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Telerehabilitation-Based Heart Rate-Synchronized Motor Imagery Music Therapy on Pain, Autonomic Function and Psychosocial Parameters in People With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06800144
- Acronym / sponsor ID
- MusicTherapy
- Conditions
- Multiple Sclerosis, MS
- Keywords
- Music Therapy in Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Istanbul Bilgi UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 10 Jul 2026 (actual)
- Study completion
- 12 Aug 2026 (actual)
- First posted
- 29 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multiple sclerosis (MS) is a chronic, inflammatory, demyelinating and progressive neurological disease of the central nervous system, often seen between the ages of 20-30. Pain is a very common symptom in people with MS, with a prevalence of 63%. Pain in MS is a symptom that negatively affects individuals' fatigue, anxiety and depression levels, quality of life and sleep quality. In addition, chronic pain affects individuals' autonomic and cognitive functions. Music therapy is defined as the systematic use of music in a therapeutic relationship that aims to improve, maintain and develop emotional, physical and mental health. Music therapy protocols synchronized with heart rate can be effective on chronic pain through the regulation of the autonomic nervous system and activation of the parasympathetic nervous system. Studies indicate that music therapy, regardless of the population applied, is effective in the management of symptoms such as pain, depression and anxiety. Motor imagery training is a method that regulates cerebral cortex activity by exposing the brain to visual information and imagination, reduces abnormal cortical activation, and thus restores the brain's ability to change. Research indicates that the most effective motor imagery training in reducing pain is motor imagery training presented in a protocol graded from simple to complex motor tasks.
The grading principle applied in motor imagery training in the form of imagining movements from simple to complex and music therapy training presented in a rhythm matched with heart rate rhythm are effective approaches on chronic pain. It is thought that the treatment protocol in which these two methods are combined and their therapeutic effects are combined in MS rehabilitation may be more effective on pain and related factors in MS. The aim of the study is to show the effects of telerehabilitation-based heart rate-synchronized music therapy protocols on pain, heart rate, fatigue, anxiety, depression, quality of life, sleep quality, and information processing speed compared to MS individuals who continue their routine treatments.
45 MS people with chronic pain will be included in the planned randomized controlled trial. The included participants will be randomized into 3 groups with 15 participants in each group. The evaluations will be performed three times before treatment, at 8th (post-treatment evaluation) and 12th weeks (follow-up evaluation). The participants' general pain intensity in the last 2 and 7 days, the presence of neuropathic pain, fatigue level, anxiety and depression levels, sleep quality, health-related quality of life and information processing speed will be evaluated. In addition, heart rate variability will be evaluated in order to evaluate the participants' autonomic functions. Telerehabilitation-based music therapy application will be given to the participants 2 days a week for 8 weeks using a videoconferencing platform under the guidance of a physiotherapist. The heart rates of the participants will be monitored throughout the session. The participants included in the first group will visualize the movements presented with the metronome sound in a rhythm matched to their heart rates, while the participants included in the second group will listen to relaxing/relaxing music without lyrics in a rhythm matched to their heart rates. When synchronization is achieved between the music rhythm and the heart rate in both groups, the music rhythm will be reduced. Participants included in the 3rd group will continue their routine treatment and will be evaluated only three times: at the beginning, after the 8th week and after the 12th week. The results obtained from this study will examine the effects of heart rate synchronized music therapy protocols on pain, autonomic function and psychosocial parameters in individuals with chronic pain and MS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Heart rate synchronized motor imagery music therapy | Experimental | Behavioral: Heart rate synchronized motor imagery music therapyParticipants included in this group will imagine the movements presented to them with a metronome sound in a rhythm synchronized with their heart rate. |
| Heart rate synchronized music therapy | Active comparator | Behavioral: Heart rate synchronized music therapyParticipants included in this group will listen to soothing/relaxing music without lyrics in a rhythm synchronized with their heart rate. |
| Control group | No intervention | –Participants included in this group will continue their routine treatment and will only be evaluated three times: at the beginning, after 8 weeks and after 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Being between the ages of 18-65.
- Having a definite MS diagnosis according to the 2017 McDonald criteria.
- Having a pain level of at least 3 and above on the numerical pain scale for at least 3 months.
- Not having had an attack in the last 3 months.
- Having a tablet or computer with an active internet connection that is suitable for videoconferencing.
Key exclusion criteria (5 listed)
- Having a serious musculoskeletal, cardiovascular, pulmonary, metabolic or other disease that would prevent participation in the study.
- Having a condition other than MS that can cause pain, such as cancer, diabetes, significant osteoarthritis or rheumatoid arthritis, based on laboratory or imaging findings
- Having a psychiatric disease (such as active psychotic disorders, severe depression, anxiety disorders) that would prevent participation in the study and having a serious cognitive disorder determined by a physician that would prevent testing
- Having a serious vision or hearing problem.
- Being pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart rate synchronized motor imagery music therapyParticipants included in this group will listen a metronome sound in a rhythm synchronized with their heart rate. | Behavioural | Heart rate synchronized motor imagery music therapy |
| Heart rate synchronized music therapyParticipants included in this group will listen to soothing/relaxing music without lyrics in a rhythm synchronized with their heart rate. | Behavioural | Heart rate synchronized music therapy |
Primary outcome
Visual Analog Scale (VAS)
Time frame: Baseline, week 8 and week 12
The general pain intensity felt by people with MS participating in the study in the last 2 and 7 days will be assessed using the Visual Analogue Pain Scale. The scale ranges from 0 mm to 100 mm, with higher values indicating greater pain intensity.
9 secondary outcomes
PainDETECT
Time frame: Baseline, week 8 and week 12
Nordic Musculoskeletal Questionnaire
Time frame: Baseline, week 8 and week 12
Central Sensitization Questionnaire- Short Form
Time frame: Baseline, week 8 and week 12
Modified Fatigue Impact Scale
Time frame: Baseline, week 8 and week 12
Hospital Anxiety and Depression Scale
Time frame: Baseline, week 8 and week 12
Preference Based MS Index
Time frame: Baseline, week 8 and week 12
Pittsburgh Sleep Quality Index
Time frame: Baseline, week 8 and week 12
Heart Rate Variability
Time frame: Baseline, week 8 and week 12
Paced Auditory Serial Addition Test
Time frame: Baseline, week 8 and week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Derived from this study: PubMed 41791797Karakas H, Ertekin O, Yavas I, Gozubatik-Celik RG, Kazdagli H, Seebacher B, Kahraman T. Effect of Telerehabilitation-Based Music Therapy and Motor Imagery on Pain, Autonomic Function, and Psychosocial Outcomes in People With Multiple Sclerosis: A Randomized Controlled Trial Protocol. Physiother Res Int. 2026 Apr;31(2):e70186. doi: 10.1002/pri.70186.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart rate synchronized motor imagery music therapy and Heart rate synchronized music therapy in people with Multiple Sclerosis, MS, run by Istanbul Bilgi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: Baseline, week 8 and week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06800144, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.